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Insignia™ Hip Stem Outcomes Study

Active Not RecruitingNA

Sponsor: Stryker Orthopaedics

Conditions: Hip Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Post-traumatic Osteoarthritis, Femoral Neck Fractures

Interventions: Insignia uncemented Hip Stem

Countries: United States

The objective of this study is to evaluate the safety and effectiveness of the Insignia™ Hip Stem for global market access and post-market clinical follow-up up to 10 years postoperative.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* The subject has signed an Institutional Review Board (IRB)-approved, study specific Informed Consent Form (ICF).
* The subject is skeletally mature
* The subject has a diagnosis as listed in the instructions for use (IFU), which include non inflammatory degenerative joint disease (including osteoarthritis or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis, correction of functional deformity, treatment of nonunion, femoral neck and trochanteric fractures.
* The subject is a candidate for a primary or revision cementless THA.
* The subject is willing and able to comply with postoperative scheduled clinical evaluations.

Exclusion Criteria:

* The subject is pregnant or breastfeeding
* The subject has an active or suspected latent infection in or about the affected hip joint at the time of study device implantation.
* The subject has any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
* The subject has bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis.
* The subject is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days).
* The subject has a known sensitivity to device materials.
* The subject is involved in any ongoing legal matter, investigation, or dispute pertaining to the operative site.
* The subject is a prisoner.

Locations (11)

Phoenix, Arizona, United States
San Francisco, California, United States
Chicago, Illinois, United States
Reno, Nevada, United States
Great Neck, New York, United States
Charlotte, North Carolina, United States
Pittsburgh, Pennsylvania, United States
Nashville, Tennessee, United States
Temple, Texas, United States
Seattle, Washington, United States
Spokane, Washington, United States